G/TBT/N/USA/2105  
14 March 2024  
(24-2300) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  UNITED STATES OF AMERICA  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Food and Drug Administration (FDA), Health and Human Services (HHS) [2136]  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the no tification shall be indicated if different from above:   
Please submit comments to: USA WTO TBT Enquiry Point, Email: usatbtep@nist.gov  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  New 
animal drugs labeling; Veterinary medicine (ICS code(s): 11.220)  
5. Title, number of pages and language(s) of the notified document:  Labeling 
Requirements for Approved or Conditionally Approved New Animal Drugs; (76 page(s), in 
English)  
6. Description of content:  Proposed rule - The Food  and Drug Administration (FDA) is 
proposing to revise the requirements for the content and format of labeling for approved 
or conditionally approved new animal drugs to provide for a more comprehensive set of 
requirements in one location in the Code of the  Federal Register (CFR). As part of this 
revision, certain current requirements would be updated and moved, and certain obsolete 
requirements would be removed. The proposed requirements would apply to the labeling 
of prescription and over -the-counter (OTC)  new animal drugs, as well as new animal 
drugs for use in animal feeds.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Consumer information, labelling; Prevention of deceptive practices and 
consumer protection; Prote ction of animal or plant life or health  
8. Relevant documents:   
89 Federal Register (FR) 18262, 13 March 2024; Title 21  Code of Federal Regulations 
(CFR) Parts 201, 500, 501, 510, 514, and 516: 
https://www.govinfo.gov/content/pkg/FR -2024-03-12/html/2024 -04840.htm  
https://www.govinfo.gov/content/pkg/FR -2024-03-12/pdf/2024 -04840.pdf  
This proposed rule is identified by Docket Number FDA -2023-N-5160. The Docket Folder 
is available on Regulations.gov at https://www.regulations.gov/docket/FDA -2023-N-
5160/document  and provides access to primary and supporting documents as well as G/TBT/N/USA/2105  
 
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  comments received. Docu ments are also accessible from Regulations.gov  by searching 
the Docket Number. WTO Members and their stakeholders are asked to submit comments 
to the USA TBT Enquiry Point . Comments received by the USA TBT Enquiry Point from 
WTO Members and their stakeholders by 4pm Eastern Time  on 10 June 2024 will be 
shared with FDA and will also be submitted to the Docket  on Regulations.gov if received 
within the comment period.  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  10 June 2024  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
https://members.wto.org/crnattachments/2024/TBT/USA/24_02027_00_e.pdf